Official Title: “The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone”

A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

This is a clinical study of an investigational drug called risperidone in the treatment of schizophrenia in adolescents. Initially children (age 2 to 12 yrs) and schizophreniform subjects were also allowed but exlcuded following protocol amendment. The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of schizophrenia. Subjects will be randomly assigned to one of two groups on enrollment and will be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose different ranges, according to the assigned study group. Initially the two dose range were 0.15-0.4 mg/day and 1.5-4mg/day but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 3.5mg/day and maximum of 6mg/day (resp. 0.35 and 0.6mg/day in low dose treatment arm)

Risperidone lower dose (0.35-0.6 mg/day [subjects >=50kg] or 0.007-0.012 mg/kg/day [subjects <50 kg]) as 0.1 mg/mL oral solution or risperidone higher dose (3.5-6 mg/day [subjects >=50 kg] or 0.07-0.12 mg/kg/day [subjects <50 kg]) as 1 mg/mL oral solution for 8 weeks. Daily dose can be given all at once or through 2 administrations (in morning and evening); the dose is increased based on efficacy and tolerability.

Intervention(s) in this Clinical Trial

• Drug: Risperidone

Primary Measures

• Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint

Secondary Measures

• Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety, tolerability and pharmacokinetics.

Inclusion Criteria:

• Subjects will be eligible for study enrollment if they: are adolescents between the ages of 13 and 17 years
• Have a confirmed diagnosis of schizophrenia and are suffering from an acute episode
• Provide their assent and parental informed consent to participate
• Are otherwise relatively healthy on the basis of a medical and physical examination
• And are able to be in-patients for approximately 2 weeks

Exclusion Criteria:

• Subjects will be excluded from the study if they: meet the criteria for psychiatric disorders other than schizophrenia
• Have moderate or severe mental retardation
• Fail to respond to treatment with at least two typical or atypical antipsychotics
• Have a history of substance dependence within the 3 months before screening
• Are considered at risk for suicidal or violent behavior
• Have a seizure disorder
• Have a history of neuroleptic malignant syndrome, similar encephalopathic syndrome, or tardive dyskinesia
• Or receive prohibited medication within a specified period before screening

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00034749

Study ID Number: CR003361

ClinicalTrials.gov Identifier: NCT00034749

Health Authority: United States: Food and Drug Administration

The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia